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J&J Asks FDA to Approve Paliperidone
Posted on 2005-11-30 12:59:00
Johnson & Johnson on Wednesday said its pharmaceutical research and development division applied for regulatory approval of Paliperidone, an investigative treatment for schizophrenia.
The new drug application with the Food and Drug Administration covers Paliperidone extended-release tablets, a once-daily oral medication. The company said the tablets use patented time-release technology that streams the drug into the blood steadily over 24 hours.
Johnson & Johnson said it has studied Paliperidone in global clinical program that included roughly 1,600 patients in 23 countries. The company said it expects to submit the drug for regulatory approval in other countries as well.
If approved, Paliperidone would be marketed by Johnson & Johnson subsidiary Janssen LP under a trade name not yet determined.
According to the company, schizophrenia affects more than 2 million Americans and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.
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